BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE CARESTATION 650 ANESTHESIA MACHINE

    MDR report key: 22810031 · Received August 14, 2025

    Report

    Report Number
    MW5174582
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    February 1, 2022
    Report Date
    August 12, 2025
    Manufacturer
    DATEX-OHMEDA, INC./GE HEALTHCARE TECHNOLOGIES INC.
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CARESTATION 650 ADJUSTABLE PRESSURE LIMITING VALVE SET AT MINIMUM AND FAILED TO RELEASE AIRWAY PRESSURE IN BAG MODE. CLINICIAN HAD TO DISCONNECT REBREATHING BAG TO PREVENT POTENTIAL BAROTRAUMA TO PATIENT DURING PROCEDURE. HOSPITAL BIO MED TEAM REPLACED THE FLAPPER VALVE AND RAN ALL DIAGNOSTIC CHECKS AND ALL PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2788696 GE CARESTATION 650 ANESTHESIA MACHINE GAS-MACHINE, ANESTHESIA BSZ DATEX-OHMEDA, INC./GE HEALTHCARE TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown